Clinical Study for the BONGO Device in the Treatment of Obstructive Sleep Apnea (OSA)
Completed · Not applicable
Conditions studied: Obstructive Sleep Apnea
In brief
Prospective, non-randomized, open label study
Key facts
- Study ID
- NCT02878590
- Run by
- InnoMed Healthscience Inc.
- People needed
- 23
- Starts
- 2016-09-01
- Expected to finish
- 2017-11-30
- Last updated by the study team
- 2019-02-19
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- • Capacity and willingness to sign informed consent
- ≥ 21 years of age
- Diagnosis of mild to moderate OSA (AHI ≥ 5 and AHI ≤ 30) within 12 months of the screening visit with the 3% hypopnea criteria
- Able to tolerate using the device during a day time trial/acclimation
- Are currently using CPAP or have been prescribed CPAP and are considered CPAP non-adherent (as per either their CPAP data card and/or verbal confirmation of a diagnosis and unwillingness to use CPAP)
You may not qualify if…
- • Nasal deformities
- Severe nasal allergies
- Rhinitis or moderate nasal congestion, acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum
- Co-morbid sleep disorders
- Currently on a hypnotic for insomnia (who have had insomnia for more than a month and take a hypnotic on a daily basis and/or transient insomnia being treated)
- Uncontrolled or serious illness, including but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure.
- Full Face Mask user
- Mouth breather
- Pregnant (Female subjects of child bearing age will be asked if they are and/or planning on becoming pregnant during the study; acceptable methods of birth control include birth control pills and barrier method)
Where it is running
- California Center for Sleep Disorders — Alameda, California, United States
Full record on ClinicalTrials.gov
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